Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment (LOSTIT)

Sahlgrenska University Hospital

Status: Begins enrollment this month

Conditions: Seizure; Epilepsy

Treatments: Other: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)

Study type: Observational

Funder types: Other

Identifiers

NCT07116330

2024-08662

Details and patient eligibility

About

A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown.

The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study.

The project has two interlinked components: a prospective single group study, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level.

Full description

Cluster design: Participating sites start with vascular risk factor intervention - patients are then offered participation in an observational 1-year study. In addition, all patients at the sites are followed in registers and compared to historic controls. Follow-up in the register study will be at least 5, but probably 10 years (until significant difference in primary analysis - Kaplan Meier).

Enrollment: 420 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Clinical study:

• First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers

Register study:

• age ≥50 with a first-ever outpatient appointment to one of the participating clinics and
• a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40)

Exclusion Criteria

Clinical study:

• Inability to consent.
• Progressive brain disease (tumour or degenerative)

Register study:

• preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation
• a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or
• progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or
• neurocognitive disorders (ICD-10: F00-F03, F051, G30, G318, G912; ATC code: N06D).

Trial design

420 participants in 1 patient group

First seizure after age 50

Description:

All patients evaluated for a first seizure after age 50 at the providers.

Treatment:

Other: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)